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- ||| RBD1016 / Suzhou Ribo
Enrollment change: A Study of RBD1016 in CHB Participants (clinicaltrials.gov) - Oct 29, 2024
P2, N=48, Recruiting, Sponsor: Suzhou Ribo Life Science Co. Ltd.
N=104 --> 48
- || IONIS-GCGRRx / Ionis
P2 data, Journal, Monotherapy: The efficacy and safety of ISIS 449884 injection as monotherapy in patients with type 2 diabetes: A randomized phase II study. (Pubmed Central) - Aug 19, 2024
N=104 --> 48 No abstract available
- || IONIS-GCGRRx / Ionis
Clinical, P2 data, Journal: ISIS 449884 Injection Add-On to Metformin in Patients with Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled, Phase II Clinical Study. (Pubmed Central) - Jul 15, 2024
No abstract available The ISIS 449884 injection add-on to metformin significantly reduced HbA1c in patients with T2DM uncontrolled by stable metformin monotherapy and showed an acceptable benefit/risk profile.
- || RBD1016 / Suzhou Ribo
PK/PD data, Journal: Analysis of the pharmacokinetics and efficacy of RBD1016 - A GalNAc-siRNA targeting Hepatitis B Virus X gene using semi-mechanistic PK/PD model. (Pubmed Central) - Jun 6, 2024
Further PK and PD data for RBD1016, including clinical data, will assist in refining the model presented here. Our current effort focused on model building for RBD1016, we anticipate that the model could apply to other GalNAc-siRNA drugs.
- RBD7022 / Suzhou Ribo, RBD5044 / Suzhou Ribo
Combination therapy with GalNAc-siRNA drugs targeting both PCSK9 and APOC3 resulted in enhanced lipid lowering in mice (Science Box 4 - Research Gateway) - May 14, 2024 - Abstract #ESC2024ESC_3187;
Conclusions- The combination of RBD7022 targeting PCSK9 and RBD5044 targeting APOC3 simultaneously reduce LDL-C and TC levels. The combination of RBD7022 and RBD5044 could be a better therapeutic option to further reduce LDL-C, particularly for mixed hyperlipidemia patients and other high-risk individuals with both high LDL-C and high TG levels.
- RBD4059 / Suzhou Ribo
First-in-human study to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of RBD4059, a GalNAc-siRNA drug targeting coagulation factor XI (FXI), in healthy subjects (Science Box 5 - Research Gateway) - May 14, 2024 - Abstract #ESC2024ESC_2502;
P1
RBD4059 was well tolerated (Table 2), all related AEs were grade 1. There was no evidence of any clinically relevant bleeding events.
- || RBD4059 / Suzhou Ribo
Enrollment change, Trial completion date: A Single Ascending Doses Phase I Study to Evaluate the Safety and Pharmacokinetics of RBD4059 in Healthy Subjects (clinicaltrials.gov) - Feb 28, 2024
P1, N=40, Recruiting, Sponsor: Suzhou Ribo Life Science Co. Ltd.
There was no evidence of any clinically relevant bleeding events. N=64 --> 40 | Trial completion date: Mar 2025 --> Dec 2024
- | Xtandi (enzalutamide capsule) / Pfizer, Astellas, IONIS-AR-2.5Rx / Flamingo Therapeutics
Phase classification, Combination therapy, Metastases: ARRx in Combination With Enzalutamide in Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - Jan 24, 2024
P1, N=9, Terminated, Sponsor: University of Michigan Rogel Cancer Center
N=64 --> 40 | Trial completion date: Mar 2025 --> Dec 2024 Phase classification: P1/2 --> P1
- | RBD1016 / Suzhou Ribo
Journal: Metabolite identification and quantitation of RBD1016 siRNA: a direct comparison of hybridization-based LC-FD and LC-HRAM assays. (Pubmed Central) - Dec 22, 2023
The two methods were successfully bridged by analyzing the same sets of study samples. Results & Both methods were found to have excellent accuracy/precision, specificity and reproducibility to support ADME and PK/PD studies of RBD1016 siRNA.
- ||| RBD5044 / Suzhou Ribo
Enrollment open: A Single and Multiple Ascending Doses Study to Evaluate the Safety and Pharmacokinetics of RBD5044 (clinicaltrials.gov) - Nov 1, 2023
P1, N=72, Recruiting, Sponsor: Suzhou Ribo Life Science Co. Ltd.
Results & Both methods were found to have excellent accuracy/precision, specificity and reproducibility to support ADME and PK/PD studies of RBD1016 siRNA. Not yet recruiting --> Recruiting
- || RBD1016 / Suzhou Ribo
Trial completion, Trial completion date, Trial primary completion date: A Single and Repeated Dose Escalation of RBD1016 in Subjects With Chronic Hepatitis B Virus (HBV) Infection (clinicaltrials.gov) - Oct 31, 2023
P1, N=40, Completed, Sponsor: Suzhou Ribo Life Science Co. Ltd.
Not yet recruiting --> Recruiting Recruiting --> Completed | Trial completion date: May 2024 --> Oct 2023 | Trial primary completion date: Jun 2023 --> Oct 2023
- ||| RBD4059 / Suzhou Ribo
Enrollment open, Trial completion date: A Single Ascending Doses Phase I Study to Evaluate the Safety and Pharmacokinetics of RBD4059 in Healthy Subjects (clinicaltrials.gov) - Oct 23, 2023
P1, N=64, Recruiting, Sponsor: Suzhou Ribo Life Science Co. Ltd.
Recruiting --> Completed | Trial completion date: May 2024 --> Oct 2023 | Trial primary completion date: Jun 2023 --> Oct 2023 Not yet recruiting --> Recruiting | Trial completion date: Oct 2024 --> Mar 2025
- ||| RBD1016 / Suzhou Ribo
Enrollment open: A Study of RBD1016 in CHB Participants (clinicaltrials.gov) - Oct 10, 2023
P2, N=104, Recruiting, Sponsor: Suzhou Ribo Life Science Co. Ltd.
Not yet recruiting --> Recruiting | Trial completion date: Oct 2024 --> Mar 2025 Not yet recruiting --> Recruiting
- |||| RBD1016 / Suzhou Ribo
New P2 trial: A Study of RBD1016 in CHB Participants (clinicaltrials.gov) - Jul 27, 2023
P2, N=104, Not yet recruiting, Sponsor: Suzhou Ribo Life Science Co. Ltd.
- RBD4059 / Suzhou Ribo
Inhibition of Factor XI using a GalNAc-siRNA RBD5049: a novel antithrombotic drug with high potency and long duration (Station 9) - May 13, 2023 - Abstract #ESC2023ESC_4980;
RBD4059 has demonstrated high potency/efficacy and long duration regarding FXI inhibition and with large safety margin. As the first siRNA based molecule targeting FXI, RBD4059 has now entered Phase 1 trial in human healthy volunteers.
- RBD5044 / Suzhou Ribo
RBD5044 - a novel anti-ApoC3 GalNAc-siRNA drug resulted in sustained and profound reduction of triglycerides in mice and Rhesus monkeys (Station 9) - May 13, 2023 - Abstract #ESC2023ESC_3680;
RBD5044 shows high efficacy, long duration and a good safety profile in preclinical studies. The Phase I trial of RBD5044 injection in healthy volunteers has been initiated in Australia.
- RBD1016 / Suzhou Ribo
Safety and antiviral activity of RBD1016, a RNAi therapeutic, in chinese subjects with chronic hepatitis B virus (HBV) infection (Poster Area) - Apr 12, 2023 - Abstract #EASLILC2023EASL_ILC_2097;
P1
Multiple doses of RBD1016 showed increased reduction in HBsAg. Preliminary safety data suggested that RBD1016 was generally safe and well tolerated.
- | Xtandi (enzalutamide capsule) / Pfizer, Astellas, IONIS-AR-2.5Rx / Flamingo Therapeutics
Trial completion date, Trial primary completion date, Combination therapy, Metastases: ARRx in Combination With Enzalutamide in Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - Apr 5, 2023
P1/2, N=9, Terminated, Sponsor: University of Michigan Rogel Cancer Center
Preliminary safety data suggested that RBD1016 was generally safe and well tolerated. Trial completion date: Jan 2022 --> Jan 2023 | Trial primary completion date: Jan 2022 --> Jan 2023
- | Xtandi (enzalutamide capsule) / Pfizer, Astellas, IONIS-AR-2.5Rx / Flamingo Therapeutics
Enrollment change, Trial termination, Combination therapy, Metastases: ARRx in Combination With Enzalutamide in Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - Jan 26, 2023
P1/2, N=9, Terminated, Sponsor: University of Michigan Rogel Cancer Center
Trial completion date: Jan 2022 --> Jan 2023 | Trial primary completion date: Jan 2022 --> Jan 2023 N=35 --> 9 | Suspended --> Terminated; Cancelled by the sponsor
- ||| RBD4059 / Suzhou Ribo
New P1 trial: A Single Ascending Doses Phase I Study to Evaluate the Safety and Pharmacokinetics of RBD4059 in Healthy Subjects (clinicaltrials.gov) - Dec 16, 2022
P1, N=64, Not yet recruiting, Sponsor: Suzhou Ribo Life Science Co. Ltd.
- ||| RBD5044 / Suzhou Ribo
New P1 trial: A Single and Multiple Ascending Doses Study to Evaluate the Safety and Pharmacokinetics of RBD5044 (clinicaltrials.gov) - Sep 14, 2022
P1, N=72, Not yet recruiting, Sponsor: Suzhou Ribo Life Science Co. Ltd.
- || RBD1016 / Suzhou Ribo
Trial completion: A Single Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of RBD1016 (clinicaltrials.gov) - Apr 26, 2022
P1, N=32, Completed, Sponsor: Suzhou Ribo Life Science Co. Ltd.
N=35 --> 9 | Suspended --> Terminated; Cancelled by the sponsor Recruiting --> Completed
- ||| RBD1016 / Suzhou Ribo
Enrollment open: A Single and Repeated Dose Escalation of RBD1016 in Subjects With Chronic Hepatitis B Virus (HBV) Infection (clinicaltrials.gov) - Apr 26, 2022
P1, N=54, Recruiting, Sponsor: Suzhou Ribo Life Science Co. Ltd.
Recruiting --> Completed Active, not recruiting --> Recruiting
- | RB-HBV008 / Suzhou Ribo
Journal: Ionizable liposomal siRNA therapeutics enables potent and persistent treatment of Hepatitis B. (Pubmed Central) - Mar 25, 2022
Moreover, the toxicity profiles suggested satisfactory safety outcomes with ten times the therapeutic window. Therefore, this study provides an effective nucleic acid delivery system and a promising RNAi agent for the treatment of hepatitis B.
- ||| RBD1016 / Suzhou Ribo
New P1 trial: A Single and Repeated Dose Escalation of RBD1016 in Subjects With Chronic Hepatitis B Virus (HBV) Infection (clinicaltrials.gov) - Aug 22, 2021
P1, N=54, Active, not recruiting, Sponsor: Suzhou Ribo Life Science Co. Ltd.
- || ION 674 / Ionis
Clinical, Journal: Intron 2 deletion generated the HLA-C*08:01:01:05 allele in a Sumi individual from Nagaland, North-East India. (Pubmed Central) - Jun 22, 2021
Therefore, this study provides an effective nucleic acid delivery system and a promising RNAi agent for the treatment of hepatitis B. HLA-C*08:01:01:05 differs from HLA-C*08:01:01:02 by one nucleotide deletion (T > -) at position 674 in intron 2.
- ||| ION 674 / Ionis
Happening now: Session 674 with Drs. @jesse8850 @RyanTedfordMD @WilcoxHeart and @DrNancySweitzer highlighting emerging areas in #HFpEF. Don't miss the discussion and debate on invasive hemodynamics: https://t.co/DechdMbVxC #ACC21 (Twitter) - May 16, 2021
- || RBD1016 / Suzhou Ribo
Enrollment open: A Single Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of RBD1016 (clinicaltrials.gov) - Apr 14, 2021
P1, N=40, Recruiting, Sponsor: Suzhou Ribo Life Science Co. Ltd.
HLA-C*08:01:01:05 differs from HLA-C*08:01:01:02 by one nucleotide deletion (T > -) at position 674 in intron 2. Not yet recruiting --> Recruiting
- | RBD1016 / Suzhou Ribo
New P1 trial: A Single Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of RBD1016 (clinicaltrials.gov) - Dec 27, 2020
P1, N=40, Not yet recruiting, Sponsor: Suzhou Ribo Life Science Co. Ltd.
- | Xtandi (enzalutamide capsule) / Pfizer, Astellas, IONIS-AR-2.5Rx / Flamingo Therapeutics
Enrollment open, Combination therapy, Metastases: ARRx in Combination With Enzalutamide in Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - Dec 24, 2020
P1/2, N=35, Recruiting, Sponsor: University of Michigan Rogel Cancer Center
Not yet recruiting --> Recruiting Suspended --> Recruiting
- | Xtandi (enzalutamide capsule) / Pfizer, Astellas, IONIS-AR-2.5Rx / Flamingo Therapeutics
Trial suspension, Combination therapy, Metastases: ARRx in Combination With Enzalutamide in Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - May 1, 2020
P1/2, N=35, Suspended, Sponsor: University of Michigan Rogel Cancer Center
Suspended --> Recruiting Recruiting --> Suspended
- | Xtandi (enzalutamide capsule) / Pfizer, Astellas, IONIS-AR-2.5Rx / Flamingo Therapeutics
Enrollment open, Combination therapy, Metastases: ARRx in Combination With Enzalutamide in Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - Apr 29, 2019
P1/2, N=35, Recruiting, Sponsor: University of Michigan Rogel Cancer Center
Recruiting --> Suspended Not yet recruiting --> Recruiting
- | Xtandi (enzalutamide capsule) / Pfizer, Astellas, IONIS-AR-2.5Rx / Flamingo Therapeutics
Phase classification, Trial completion date, Trial initiation date, Trial primary completion date, Combination therapy, Metastases: ARRx in Combination With Enzalutamide in Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - Mar 14, 2019
P1/2, N=35, Not yet recruiting, Sponsor: University of Michigan Rogel Cancer Center
Not yet recruiting --> Recruiting Phase classification: P2 --> P1/2 | Trial completion date: Nov 2023 --> Apr 2024 | Initiation date: Oct 2018 --> Apr 2019 | Trial primary completion date: Nov 2023 --> Apr 2024
- | Xtandi (enzalutamide capsule) / Pfizer, Astellas, IONIS-AR-2.5Rx / Flamingo Therapeutics
Trial initiation date, Combination therapy, Metastases: ARRx in Combination With Enzalutamide in Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - Mar 15, 2018
P2, N=38, Not yet recruiting, Sponsor: University of Michigan Cancer Center
Phase classification: P2 --> P1/2 | Trial completion date: Nov 2023 --> Apr 2024 | Initiation date: Oct 2018 --> Apr 2019 | Trial primary completion date: Nov 2023 --> Apr 2024 Initiation date: Feb 2018 --> Oct 2018
- | Xtandi (enzalutamide capsule) / Pfizer, Astellas, IONIS-AR-2.5Rx / Flamingo Therapeutics
Trial initiation date, Combination therapy, Metastases: ARRx in Combination With Enzalutamide in Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - Dec 21, 2017
P2, N=38, Not yet recruiting, Sponsor: University of Michigan Cancer Center
Initiation date: Feb 2018 --> Oct 2018 Initiation date: Nov 2017 --> Feb 2018
- | Xtandi (enzalutamide capsule) / Pfizer, Astellas, IONIS-AR-2.5Rx / Flamingo Therapeutics
New P2 trial, Combination therapy, Metastases: ARRx in Combination With Enzalutamide in Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - Oct 3, 2017
P2, N=38, Not yet recruiting, Sponsor: University of Michigan Cancer Center
- || IONIS-GCGRRx / Ionis
Trial primary completion date: Safety, Tolerability and Efficacy of ISIS-GCGRRx in Patients With Type 2 Diabetes (clinicaltrials.gov) - Oct 19, 2016
P2, N=80, Active, not recruiting, Sponsor: Ionis Pharmaceuticals, Inc.
Initiation date: Nov 2017 --> Feb 2018 Trial primary completion date: Sep 2016 --> Dec 2016
- | IONIS-GCGRRx / Ionis
Enrollment closed: Study to Evaluate the Effect of ISIS GCGRRx on Hepatic Lipid and Glycogen Content in Type 2 Diabetes (clinicaltrials.gov) - Oct 18, 2016
P2a, N=15, Active, not recruiting, Sponsor: Ionis Pharmaceuticals, Inc.
Trial primary completion date: Sep 2016 --> Dec 2016 Recruiting --> Active, not recruiting
- | IONIS-AR-2.5Rx / Flamingo Therapeutics
Trial completion, Enrollment change, Metastases: Phase I Open Label Dose Escalation Study to Investigate the Safety & Pharmacokinetics of AZD5312 in Patients With Androgen Receptor Tumors (clinicaltrials.gov) - Jul 14, 2016
P1, N=32, Completed, Sponsor: AstraZeneca
Recruiting --> Active, not recruiting Active, not recruiting --> Completed | N=90 --> 32
- IONIS-GCGRRx / Ionis
New P2a trial: Study to Evaluate the Effect of ISIS GCGRRx on Hepatic Lipid and Glycogen Content in Type 2 Diabetes (clinicaltrials.gov) - Jul 6, 2016
P2a, N=15, Recruiting, Sponsor: Ionis Pharmaceuticals, Inc.
- IONIS-GCGRRx / Ionis
Enrollment closed: Safety, Tolerability and Efficacy of ISIS-GCGRRx in Patients With Type 2 Diabetes (clinicaltrials.gov) - Jul 5, 2016
P2, N=80, Active, not recruiting, Sponsor: Ionis Pharmaceuticals, Inc.
Active, not recruiting --> Completed | N=90 --> 32 Recruiting --> Active, not recruiting
- || IONIS-AR-2.5Rx / Flamingo Therapeutics
Enrollment closed, Metastases: Phase I Open Label Dose Escalation Study to Investigate the Safety & Pharmacokinetics of AZD5312 in Patients With Androgen Receptor Tumors (clinicaltrials.gov) - Jan 15, 2016
P1, N=90, Active, not recruiting, Sponsor: AstraZeneca
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- ||||| IONIS-GCGRRx / Ionis
New P2 trial: Safety, Tolerability and Efficacy of ISIS-GCGRRx in Patients With Type 2 Diabetes (clinicaltrials.gov) - Oct 22, 2015
P2, N=80, Recruiting, Sponsor: Isis Pharmaceuticals
- |||| IONIS-GCGRRx / Ionis
Trial completion, Trial primary completion date: Safety, Tolerability and Efficacy of ISIS-GCGRRx in Type 2 Diabetes (clinicaltrials.gov) - Nov 25, 2014
P2, N=77, Completed, Sponsor: Isis Pharmaceuticals
Recruiting --> Active, not recruiting Active, not recruiting --> Completed | Trial primary completion date: Dec 2014 --> May 2014
- ||| IONIS-AR-2.5Rx / Flamingo Therapeutics
Enrollment open, Metastases: Phase I Open Label Dose Escalation Study to Investigate the Safety & Pharmacokinetics of AZD5312 in Patients With Androgen Receptor Tumors (clinicaltrials.gov) - Jun 4, 2014
P1, N=90, Recruiting, Sponsor: AstraZeneca
Active, not recruiting --> Completed | Trial primary completion date: Dec 2014 --> May 2014 Not yet recruiting --> Recruiting
- ||| IONIS-AR-2.5Rx / Flamingo Therapeutics
New P1 trial, Metastases: Phase I Open Label Dose Escalation Study to Investigate the Safety & Pharmacokinetics of AZD5312 in Patients With Androgen Receptor Tumors (clinicaltrials.gov) - May 19, 2014
P1, N=90, Not yet recruiting, Sponsor: AstraZeneca
- ||| IONIS-GCGRRx / Ionis
Enrollment closed: Safety, Tolerability and Efficacy of ISIS-GCGRRx in Type 2 Diabetes (clinicaltrials.gov) - Nov 11, 2013
P2, N=72, Active, not recruiting, Sponsor: Isis Pharmaceuticals
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- ||||| IONIS-GCGRRx / Ionis
New P2 trial: Safety, Tolerability and Efficacy of ISIS-GCGRRx in Type 2 Diabetes (clinicaltrials.gov) - Jun 20, 2013
P2, N=72, Active, not recruiting, Sponsor: Isis Pharmaceuticals