Phase 1 Monotherapy Clinical Trials

7 recruitingPhase 1

What is a Phase 1 trial?

Phase 1 trials test a new treatment in a small group of people for the first time. The primary goal is to evaluate safety, determine a safe dosage range, and identify side effects. These studies typically enroll 20 to 80 participants.

Showing 17 of 7 trials

Recruiting
Phase 1Phase 2

Mirdametinib Monotherapy in Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF).

NF1Cutaneous NeurofibromaMonotherapy
Johns Hopkins University24 enrolled1 locationNCT06159166
Completed
Phase 1

Comparative assessment of the absorption of a generic formulation of N-acetyl-5-methoxytryptamine prolonged release tablet against the innovator N-acetyl-5-methoxytryptamine prolonged release tablet conducted under fed conditions in healthy male and female volunteers.

N-acetyl-5-methoxytryptamine is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.
Zenith Technology Corporation Limited28 enrolled1 locationACTRN12622000966796
Completed
Phase 1

Comparative assessment of the absorption of a generic formulation of N-acetyl-5-methoxytryptamine prolonged release tablet against the innovator N-acetyl-5-methoxytryptamine prolonged release tablet conducted under fasting conditions and at steady state in healthy male and female volunteers.

N-acetyl-5-methoxytryptamine is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.
Zenith Technology Corporation Limited28 enrolled1 locationACTRN12622000957796
Completed
Phase 1

Comparative assessment of the absorption of a generic formulation of N-acetyl-5-methoxytryptamine prolonged release tablet against the innovator N-acetyl-5-methoxytryptamine prolonged release tablet conducted under fasting conditions in healthy male and female volunteers.

N-acetyl-5-methoxytryptamine is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.
Zenith Technology Corporation Limited28 enrolled1 locationACTRN12622000956707
Completed
Phase 1

Comparative assessment of the absorption of a generic formulation of N-[2-(5-Methoxyindol-3-yl)ethyl]acetamide prolonged release tablet against the innovator N-[2-(5-Methoxyindol-3-yl)ethyl]acetamide prolonged release tablet conducted under fed conditions in healthy male and female volunteers.

N-[2-(5-Methoxyindol-3-yl)ethyl]acetamide is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.
Zenith Technology Corporation Limited28 enrolled1 locationACTRN12622000126718
Completed
Phase 1

Comparative assessment of the absorption of a generic formulation of N-[2-(5-Methoxyindol-3-yl)ethyl]acetamide prolonged release tablet against the innovator N-[2-(5-Methoxyindol-3-yl)ethyl]acetamide prolonged release tablet conducted under fasting conditions and at steady state in healthy male and female volunteers.

N-[2-(5-Methoxyindol-3-yl)ethyl]acetamide is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.
Zenith Technology Corporation Limited28 enrolled1 locationACTRN12622000109707
Completed
Phase 1

Comparative assessment of the absorption of a generic formulation of N-[2-(5-Methoxyindol-3-yl)ethyl]acetamide prolonged release tablet against the innovator N-[2-(5-Methoxyindol-3-yl)ethyl]acetamide prolonged release tablet conducted under fasting conditions in healthy male and female volunteers.

N-[2-(5-Methoxyindol-3-yl)ethyl]acetamide is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.
Zenith Technology Corporation Limited28 enrolled1 locationACTRN12622000108718