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

Traws Pharma, Inc.

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers Only

Treatments: Drug: Placebo; Drug: 83-0060

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06402136

CT-2024-CTN-00084-1 (Other Identifier)

83-0060-0001

Details and patient eligibility

About

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

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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57 participants in 8 patient groups

Single dose level 1 or placebo

Experimental group

Description:

Dose level 1. SAD study part.

Treatment:

Drug: 83-0060

Drug: Placebo

Single dose level 2 or placebo

Experimental group

Description:

Dose level 2. SAD study part.

Treatment:

Drug: 83-0060

Drug: Placebo

Single dose level 3 or placebo

Experimental group

Description:

Dose level 3. SAD study part.

Treatment:

Drug: 83-0060

Drug: Placebo

Single dose level 4 or placebo

Experimental group

Description:

Dose level 4. SAD study part.

Treatment:

Drug: 83-0060

Drug: Placebo

Single dose level 5 or placebo

Experimental group

Description:

Dose level 5. SAD study part.

Treatment:

Drug: 83-0060

Drug: Placebo

Multiple dose level 1 or placebo

Experimental group

Description:

Dose level 1. MAD study part.

Treatment:

Drug: 83-0060

Drug: Placebo

Multiple dose level 2 or placebo

Experimental group

Description:

Dose level 2. MAD study part.

Treatment:

Drug: 83-0060

Drug: Placebo

Multiple dose level 3 or placebo

Experimental group

Description:

Dose level 3. MAD study part.

Treatment:

Drug: 83-0060

Drug: Placebo