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CompletedNCT06402136Updated Jan 22, 2026

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

A Phase 1 interventional study of 83-0060 and Placebo in Healthy Volunteers Only, sponsored by Traws Pharma, Inc.. Completed at 1 site in Australia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-22.

Sponsored by Traws Pharma, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
57
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Healthy Volunteers Only
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
57 participants (actual)

Study arms

  • Experimental
    Single dose level 1 or placebo

    Dose level 1. SAD study part.

    Drug: 83-0060 · Drug: Placebo

  • Experimental
    Single dose level 2 or placebo

    Dose level 2. SAD study part.

    Drug: 83-0060 · Drug: Placebo

  • Experimental
    Single dose level 3 or placebo

    Dose level 3. SAD study part.

    Drug: 83-0060 · Drug: Placebo

  • Experimental
    Single dose level 4 or placebo

    Dose level 4. SAD study part.

    Drug: 83-0060 · Drug: Placebo

  • Experimental
    Single dose level 5 or placebo

    Dose level 5. SAD study part.

    Drug: 83-0060 · Drug: Placebo

  • Experimental
    Multiple dose level 1 or placebo

    Dose level 1. MAD study part.

    Drug: 83-0060 · Drug: Placebo

  • Experimental
    Multiple dose level 2 or placebo

    Dose level 2. MAD study part.

    Drug: 83-0060 · Drug: Placebo

  • Experimental
    Multiple dose level 3 or placebo

    Dose level 3. MAD study part.

    Drug: 83-0060 · Drug: Placebo

Interventions

  • Drug83-0060

    Oral MPro inhibitor

  • DrugPlacebo

    Placebo

05

What researchers measure

Primary outcomes

  1. Incidence of AEs

    Incidence of Adverse Events observed during the study

    Time frame: 8 days in SAD part, 17 days for MAD part

  2. Incidence of drug-related AEs

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

    Time frame: 8 days in SAD part, 17 days for MAD part

  3. Incidence of SAEs

    Incidence of Serious Adverse Events observed during the study

    Time frame: 8 days in SAD part, 17 days for MAD part

  4. Incidence of lab deviations

    Incidence of clinically relevant deviations in the clinical laboratory parameters

    Time frame: 8 days in SAD part, 17 days for MAD part

Secondary outcomes

  1. Plasma concentration

    Plasma concentration, ng/mL

    Time frame: 8 days in SAD part, 17 days for MAD part

Other outcomes

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

    Serum PD endpoint

    Time frame: 24 hours in SAD part, 11 days for MAD part

06

Study locations

1 site
  • Scientia Clinical Research
    Sydney, Greater Sydney Area NSW 2031, Australia
07

Registry details

Key details

Study ID
NCT06402136
Lead sponsor
Traws Pharma, Inc.
Collaborators
Trawsfynydd Therapeutics AU Pty Ltd
Responsible party
Sponsor
First posted
May 7, 2024
Start date
Apr 15, 2024
Primary completion
Aug 9, 2024
Completion
Sep 30, 2024
Last update
Jan 22, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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