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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

In context

Lead sponsor

Traws Pharma, Inc. is the lead sponsor of 35 studies on the registry; 4 are open to participants now.

Browse Traws Pharma, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Must have given written 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. (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 .
  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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

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

06

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

07

Study locations

1 site
  • Scientia Clinical Research
    Sydney, Greater Sydney Area NSW 2031, Australia
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2024 to primary completion in Aug 2024, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 2, 2024
First posted
May 7, 2024
StartActual
Apr 15, 2024
Primary completionActual
Aug 9, 2024
CompletionActual
Sep 30, 2024
Last update
Jan 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

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 ↗

Not currently enrolling

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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Discussion

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