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

PHASE1RECRUITING

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

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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.

Adult males and females, 18 to 65 years of age (inclusive) at screening.

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

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.

History of surgery or hospitalisation within 30 days prior to screening, or surgery planned during the study.

Acute infections within 4 weeks prior to screening or current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications.

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.

Any history of malignant disease in the last 5 years (excludes surgically resected skin squamous cell or basal cell carcinoma).

Any screening laboratory result outside the normal laboratory reference range (as confirmed upon repeated testing) and deemed clinically significant by the PI.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : Yes

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-04-15

Primary completion: 2024-08-09

Study completion finish: 2024-12-01

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT06402136

Intervention or treatment

DRUG: 83-0060

DRUG: Placebo

Conditions

• Healthy Volunteers Only

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Condition: Healthy Volunteers Only
DRUG: 83-0060 and other drugs
Sydney, Greater Sydney Area, Australia
Sponsor: Traws Pharma, Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Scientia Clinical Research

Research sites nearby

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Scientia Clinical Research
Sydney, Greater Sydney Area, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Single dose level 1 or placebo Dose level 1. SAD study part.	DRUG: 83-0060 Oral MPro inhibitor
EXPERIMENTAL: Single dose level 2 or placebo Dose level 2. SAD study part.	DRUG: 83-0060 Oral MPro inhibitor
EXPERIMENTAL: Single dose level 3 or placebo Dose level 3. SAD study part.	DRUG: 83-0060 Oral MPro inhibitor
EXPERIMENTAL: Single dose level 4 or placebo Dose level 4. SAD study part.	DRUG: 83-0060 Oral MPro inhibitor
EXPERIMENTAL: Single dose level 5 or placebo Dose level 5. SAD study part.	DRUG: 83-0060 Oral MPro inhibitor
EXPERIMENTAL: Multiple dose level 1 or placebo Dose level 1. MAD study part.	DRUG: 83-0060 Oral MPro inhibitor
EXPERIMENTAL: Multiple dose level 2 or placebo Dose level 2. MAD study part.	DRUG: 83-0060 Oral MPro inhibitor
EXPERIMENTAL: Multiple dose level 3 or placebo Dose level 3. MAD study part.	DRUG: 83-0060 Oral MPro inhibitor

What is the study measuring?

Primary outcome

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

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Plasma concentration	Plasma concentration, ng/mL	8 days in SAD part, 17 days for MAD part

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

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