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

NCT06402136 | Completed Phase 1

• 2 other identifiers: 83-0060-0001CT-2024-CTN-00084-1
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers Only

Outcome Measures

Primary Outcomes (4)

• Incidence of AEs

  Incidence of Adverse Events observed during the study

  8 days in SAD part, 17 days for MAD part

• Incidence of drug-related AEs

  Incidence of Adverse Events observed during the study deemed related to the study drug by the Investigator

  8 days in SAD part, 17 days for MAD part

• Incidence of SAEs

  Incidence of Serious Adverse Events observed during the study

  8 days in SAD part, 17 days for MAD part

• Incidence of lab deviations

  Incidence of clinically relevant deviations in the clinical laboratory parameters

  8 days in SAD part, 17 days for MAD part

Secondary Outcomes (1)

• Plasma concentration

  8 days in SAD part, 17 days for MAD part

Other Outcomes (1)

• Pharmacodynamics (PD) of single and multiple oral doses of 83-0060

  24 hours in SAD part, 11 days for MAD part

Study Arms (8)

Single dose level 1 or placebo

EXPERIMENTAL

Dose level 1. SAD study part.

Drug: 83-0060; Drug: Placebo

Single dose level 2 or placebo

EXPERIMENTAL

Dose level 2. SAD study part.

Drug: 83-0060; Drug: Placebo

Single dose level 3 or placebo

EXPERIMENTAL

Dose level 3. SAD study part.

Drug: 83-0060; Drug: Placebo

Single dose level 4 or placebo

EXPERIMENTAL

Dose level 4. SAD study part.

Drug: 83-0060; Drug: Placebo

Single dose level 5 or placebo

EXPERIMENTAL

Dose level 5. SAD study part.

Drug: 83-0060; Drug: Placebo

Multiple dose level 1 or placebo

EXPERIMENTAL

Dose level 1. MAD study part.

Drug: 83-0060; Drug: Placebo

Multiple dose level 2 or placebo

EXPERIMENTAL

Dose level 2. MAD study part.

Drug: 83-0060; Drug: Placebo

Multiple dose level 3 or placebo

EXPERIMENTAL

Dose level 3. MAD study part.

Drug: 83-0060; Drug: Placebo

Interventions

83-0060 DRUG

Oral MPro inhibitor

Multiple dose level 1 or placebo; Multiple dose level 2 or placebo; Multiple dose level 3 or placebo; Single dose level 1 or placebo; Single dose level 2 or placebo; Single dose level 3 or placebo; Single dose level 4 or placebo; Single dose level 5 or placebo

Placebo DRUG

Placebo

Multiple dose level 1 or placebo; Multiple dose level 2 or placebo; Multiple dose level 3 or placebo; Single dose level 1 or placebo; Single dose level 2 or placebo; Single dose level 3 or placebo; Single dose level 4 or placebo; Single dose level 5 or placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Adult males and females, 18 to 65 years of age (inclusive) at screening.
• Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2, with a body weight (to 1 decimal place) ≥ 50.0 kg at screening.

You may not qualify if:

• 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.
• History of surgery or hospitalisation within 30 days prior to screening, or surgery planned during the study.
• Acute infections within 4 weeks prior to screening or current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications.
• 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.
• Any history of malignant disease in the last 5 years (excludes surgically resected skin squamous cell or basal cell carcinoma).
• Any screening laboratory result outside the normal laboratory reference range (as confirmed upon repeated testing) and deemed clinically significant by the PI.

Sponsors & Collaborators

• Traws Pharma, Inc.: lead
• Trawsfynydd Therapeutics AU Pty Ltd: collaborator

Study Sites (1)

Scientia Clinical Research

Sydney, Greater Sydney Area, NSW 2031, Australia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-Blind, Placebo-Controlled
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 7, 2024
• Study Start: April 15, 2024
• Primary Completion: August 9, 2024
• Study Completion: September 30, 2024
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

AU (1)