Clinical trial NCT06402136: Evaluation Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of 83-0060 in Healthy Volunteers
Official title: A Randomised, Double-Blind, Placebo-Controlled, First-in-Human Study of Orally Administered 83-0060 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of 83-0060 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers Only
Lead sponsor: Traws Pharma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Trawsfynydd Therapeutics AU Pty Ltd
First posted: 2024-05-07
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of AEs
timeFrame: 8 days in SAD part, 17 days for MAD part
measure: Incidence of drug-related AEs
timeFrame: 8 days in SAD part, 17 days for MAD part
measure: Incidence of SAEs
timeFrame: 8 days in SAD part, 17 days for MAD part
measure: Incidence of lab deviations
timeFrame: 8 days in SAD part, 17 days for MAD part
Secondary outcomes:
measure: Plasma concentration
timeFrame: 8 days in SAD part, 17 days for MAD part
Other outcomes:
measure: Pharmacodynamics (PD) of single and multiple oral doses of 83-0060
timeFrame: 24 hours in SAD part, 11 days for MAD part
Locations:
city: Sydney
country: Australia
facility: Scientia Clinical Research
state: Greater Sydney Area
Study officials:
References: