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

Phase 1

Recruiting

• Conditions: Healthy Volunteers Only
• Interventions: Drug: 83-0060; Drug: Placebo

• Registration Number: NCT06402136
• Lead Sponsor: Traws Pharma, Inc.

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.

Study Timeline

• Study Start: 2024-04-15
• Study First Submitted: 2024-05-02
• Study First Submitted QC: 2024-05-02
• Study First Posted: 2024-05-07
• Primary Completion: 2024-08-09
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-14
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Multiple dose level 1 or placebo	83-0060	Dose level 1. MAD study part.
Multiple dose level 3 or placebo	83-0060	Dose level 3. MAD study part.
Single dose level 1 or placebo	Placebo	Dose level 1. SAD study part.
Single dose level 2 or placebo	83-0060	Dose level 2. SAD study part.
Single dose level 2 or placebo	Placebo	Dose level 2. SAD study part.
Single dose level 3 or placebo	83-0060	Dose level 3. SAD study part.
Single dose level 3 or placebo	Placebo	Dose level 3. SAD study part.
Single dose level 4 or placebo	83-0060	Dose level 4. SAD study part.
Single dose level 4 or placebo	Placebo	Dose level 4. SAD study part.
Single dose level 5 or placebo	83-0060	Dose level 5. SAD study part.
Single dose level 5 or placebo	Placebo	Dose level 5. SAD study part.
Multiple dose level 1 or placebo	Placebo	Dose level 1. MAD study part.
Multiple dose level 2 or placebo	83-0060	Dose level 2. MAD study part.
Multiple dose level 2 or placebo	Placebo	Dose level 2. MAD study part.
Multiple dose level 3 or placebo	Placebo	Dose level 3. MAD study part.
Single dose level 1 or placebo	83-0060	Dose level 1. SAD study part.

Primary Outcome Measures

Name	Time	Method
Incidence of AEs	8 days in SAD part, 17 days for MAD part	Incidence of Adverse Events observed during the study
Incidence of drug-related AEs	8 days in SAD part, 17 days for MAD part	Incidence of Adverse Events observed during the study deemed related to the study drug by the Investigator
Incidence of SAEs	8 days in SAD part, 17 days for MAD part	Incidence of Serious Adverse Events observed during the study
Incidence of lab deviations	8 days in SAD part, 17 days for MAD part	Incidence of clinically relevant deviations in the clinical laboratory parameters

Secondary Outcome Measures

Name	Time	Method
Plasma concentration	8 days in SAD part, 17 days for MAD part	Plasma concentration, ng/mL

Trial Locations

Locations (1)

Scientia Clinical Research; 🇦🇺 Sydney, Greater Sydney Area, Australia