Evaluation Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of 83-0060 in Healthy Volunteers

NCT ID: NCT06402136

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2024-09-30

Brief Summary

This is a clinical study aiming to assess pharmacokinetics, pharmacodynamics and preliminary efficacy of 83-0060 in Healthy Volunteers

Detailed Description

This is a Phase 1, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, PK, PD of orally administered 83-0060 in Healthy Volunteers. The study will be conducted in 2 parts: a single ascending dose (SAD) part at up to 5 dose levels and a multiple ascending dose (MAD) part at up to 3 dose levels. Evaluation of dose levels will be conducted in a sequential fashion with lower dose levels evaluated first in the sequence.

Conditions

Healthy Volunteers Only

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Single dose level 1 or placebo

Dose level 1. SAD study part.

Group Type: EXPERIMENTAL

83-0060

Intervention Type: DRUG

Oral MPro inhibitor

Placebo

Intervention Type: DRUG

Placebo

Single dose level 2 or placebo

Dose level 2. SAD study part.

Group Type: EXPERIMENTAL

83-0060

Intervention Type: DRUG

Oral MPro inhibitor

Placebo

Intervention Type: DRUG

Placebo

Single dose level 3 or placebo

Dose level 3. SAD study part.

Group Type: EXPERIMENTAL

83-0060

Intervention Type: DRUG

Oral MPro inhibitor

Placebo

Intervention Type: DRUG

Placebo

Single dose level 4 or placebo

Dose level 4. SAD study part.

Group Type: EXPERIMENTAL

83-0060

Intervention Type: DRUG

Oral MPro inhibitor

Placebo

Intervention Type: DRUG

Placebo

Single dose level 5 or placebo

Dose level 5. SAD study part.

Group Type: EXPERIMENTAL

83-0060

Intervention Type: DRUG

Oral MPro inhibitor

Placebo

Intervention Type: DRUG

Placebo

Multiple dose level 1 or placebo

Dose level 1. MAD study part.

Group Type: EXPERIMENTAL

83-0060

Intervention Type: DRUG

Oral MPro inhibitor

Placebo

Intervention Type: DRUG

Placebo

Multiple dose level 2 or placebo

Dose level 2. MAD study part.

Group Type: EXPERIMENTAL

83-0060

Intervention Type: DRUG

Oral MPro inhibitor

Placebo

Intervention Type: DRUG

Placebo

Multiple dose level 3 or placebo

Dose level 3. MAD study part.

Group Type: EXPERIMENTAL

83-0060

Intervention Type: DRUG

Oral MPro inhibitor

Placebo

Intervention Type: DRUG

Placebo

Interventions

83-0060

Oral MPro inhibitor

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.

2. Adult males and females, 18 to 65 years of age (inclusive) at screening.

3. Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2, with a body weight (to 1 decimal place) ≥ 50.0 kg at screening.

Exclusion Criteria

1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery within the past 3 months determined by the PI to be clinically significant.

2. History of surgery or hospitalisation within 30 days prior to screening, or surgery planned during the study.

3. Acute infections within 4 weeks prior to screening or current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications.

4. Presence or history of any abnormality or illness, including gastrointestinal surgery, which in the opinion of the PI may affect absorption, distribution, metabolism or elimination of the study drug.

5. Any history of malignant disease in the last 5 years (excludes surgically resected skin squamous cell or basal cell carcinoma).

6. Any screening laboratory result outside the normal laboratory reference range (as confirmed upon repeated testing) and deemed clinically significant by the PI.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Trawsfynydd Therapeutics AU Pty Ltd

UNKNOWN

Sponsor Role: collaborator

Traws Pharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Scientia Clinical Research

Sydney, Greater Sydney Area, Australia

Countries

Australia

Other Identifiers

CT-2024-CTN-00084-1

Identifier Type: OTHER

Identifier Source: secondary_id

83-0060-0001

Identifier Type: -

Identifier Source: org_study_id