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- || 2-isopropyl-3H-naphtho[2,1-d]imidazole-4,5-dione (KL1333) / Abliva, KT&G Corp
P1 data, Journal: Optimizing rare disorder trials: a phase 1a/1b randomized study of KL1333 in adults with mitochondrial disease. (Pubmed Central) - Jan 8, 2025
Importantly, the data from the trial support efficacy of KL1333 based on improvements in fatigue and functional strength and endurance. Furthermore, the study highlights the value in using phase 1 studies to capture data that helps optimize later phase efficacy trial design.
- || 2-isopropyl-3H-naphtho[2,1-d]imidazole-4,5-dione (KL1333) / Abliva, KT&G Corp
Enrollment closed: FALCON: Efficacy of KL1333 in Adult Patients With Primary Mitochondrial Disease (clinicaltrials.gov) - Oct 26, 2023
P2, N=180, Active, not recruiting, Sponsor: Abliva AB
Furthermore, the study highlights the value in using phase 1 studies to capture data that helps optimize later phase efficacy trial design. Recruiting --> Active, not recruiting
- ||| 2-isopropyl-3H-naphtho[2,1-d]imidazole-4,5-dione (KL1333) / Abliva, KT&G Corp
Enrollment open: FALCON: Efficacy of KL1333 in Adult Patients With Primary Mitochondrial Disease (clinicaltrials.gov) - Jan 30, 2023
P2, N=180, Recruiting, Sponsor: Abliva AB
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- |||| 2-isopropyl-3H-naphtho[2,1-d]imidazole-4,5-dione (KL1333) / Abliva, KT&G Corp
New P2 trial: FALCON: Efficacy of KL1333 in Adult Patients With Primary Mitochondrial Disease (clinicaltrials.gov) - Dec 14, 2022
P2, N=180, Not yet recruiting, Sponsor: Abliva AB
- || KL1333 / Abliva, Yungjin Pharma
BioStock: Celebrating IND approval Abliva eyes next step with KL1333 https://t.co/l5Bn2eCL5o (Twitter) - Mar 7, 2022
- ||| 2-isopropyl-3H-naphtho[2,1-d]imidazole-4,5-dione (KL1333) / Abliva, KT&G Corp
Trial completion: A Phase Ia/Ib, SAD and MAD Study of of KL1333 in Healthy Subjects and Patients With Primary Mitochondrial Disease (clinicaltrials.gov) - Oct 20, 2021
P1a/1b, N=72, Completed, Sponsor: Abliva AB
Not yet recruiting --> Recruiting Recruiting --> Completed
- || 2-isopropyl-3H-naphtho[2,1-d]imidazole-4,5-dione (KL1333) / Abliva, KT&G Corp
Trial completion: Drug-drug Interaction Study of KL1333 in Healthy Subjects (clinicaltrials.gov) - Oct 19, 2021
P1, N=14, Completed, Sponsor: Abliva AB
Recruiting --> Completed Recruiting --> Completed
- | 2-isopropyl-3H-naphtho[2,1-d]imidazole-4,5-dione (KL1333) / Abliva, KT&G Corp
New P1 trial: Drug-drug Interaction Study of KL1333 in Healthy Subjects (clinicaltrials.gov) - Nov 24, 2020
P1, N=14, Recruiting, Sponsor: Abliva AB
- || 2-isopropyl-3H-naphtho[2,1-d]imidazole-4,5-dione (KL1333) / Abliva, KT&G Corp
Trial completion date, Trial primary completion date: A Phase Ia/Ib, SAD and MAD Study of of KL1333 in Healthy Subjects and Patients With Primary Mitochondrial Disease (clinicaltrials.gov) - Oct 14, 2020
P1a/1b, N=72, Recruiting, Sponsor: NeuroVive Pharmaceutical AB
Recruiting --> Completed Trial completion date: Mar 2020 --> Feb 2021 | Trial primary completion date: Mar 2020 --> Jan 2021
- ||| 2-isopropyl-3H-naphtho[2,1-d]imidazole-4,5-dione (KL1333) / Abliva, KT&G Corp
New P1 trial: A Phase Ia/Ib, SAD and MAD Study of of KL1333 in Healthy Subjects and Patients With Primary Mitochondrial Disease (clinicaltrials.gov) - Mar 25, 2019
P1a/1b, N=72, Recruiting, Sponsor: NeuroVive Pharmaceutical AB
- ||| 2-isopropyl-3H-naphtho[2,1-d]imidazole-4,5-dione (KL1333) / Abliva, KT&G Corp
Trial completion: Safety, Tolerability and Pharmacokinetic Study of KL1333 in Healthy Male Volunteers (clinicaltrials.gov) - Apr 27, 2018
P1, N=60, Completed, Sponsor: Yungjin Pharm. Co., Ltd.
Trial completion date: Mar 2020 --> Feb 2021 | Trial primary completion date: Mar 2020 --> Jan 2021 Recruiting --> Completed
- || 2-isopropyl-3H-naphtho[2,1-d]imidazole-4,5-dione (KL1333) / Abliva, KT&G Corp
Trial completion date, Trial primary completion date: Safety, Tolerability and Pharmacokinetic Study of KL1333 in Healthy Male Volunteers (clinicaltrials.gov) - Mar 3, 2018
P1, N=80, Recruiting, Sponsor: Yungjin Pharm. Co., Ltd.
Recruiting --> Completed Trial completion date: Mar 2018 --> Apr 2018 | Trial primary completion date: Mar 2018 --> Apr 2018
- ||| 2-isopropyl-3H-naphtho[2,1-d]imidazole-4,5-dione (KL1333) / Abliva, KT&G Corp
Enrollment open, Enrollment change, Trial initiation date, Trial primary completion date: Safety, Tolerability and Pharmacokinetic Study of KL1333 in Healthy Male Volunteers (clinicaltrials.gov) - Dec 21, 2017
P1, N=80, Recruiting, Sponsor: Yungjin Pharm. Co., Ltd.
Trial completion date: Mar 2018 --> Apr 2018 | Trial primary completion date: Mar 2018 --> Apr 2018 Not yet recruiting --> Recruiting | N=10 --> 80 | Initiation date: Mar 2017 --> Jun 2017 | Trial primary completion date: Jun 2017 --> May 2018
- 2-isopropyl-3H-naphtho[2,1-d]imidazole-4,5-dione (KL1333) / Abliva, KT&G Corp
New P1 trial: Safety, Tolerability and Pharmacokinetic Study of KL1333 in Healthy Male Volunteers (clinicaltrials.gov) - Feb 16, 2017
P1, N=10, Not yet recruiting, Sponsor: KT&G Life Sciences Corp