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

• ClinicalTrials.gov Identifier: NCT06402136
• Recruitment Status: Recruiting
• First Posted: May 7, 2024
• Last Update Posted: May 7, 2024
• Sponsor: Traws Pharma, Inc.
• Information provided by (Responsible Party): Traws Pharma, Inc.

Tracking Information

• First Submitted Date: May 2, 2024
• First Posted Date: May 7, 2024
• Last Update Posted Date: May 7, 2024
• Actual Study Start Date: April 15, 2024
• Estimated Primary Completion Date: July 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 2, 2024)

Plasma concentration [ Time Frame: 72 hours for SAD, 10 days for MAD ]

Plasma concentration, ng/mL

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: May 2, 2024)

• Incidence of AEs [ Time Frame: 8 days in SAD part, 17 days for MAD part ]
  Incidence of Adverse Events observed during the study
• Incidence of drug-related AEs [ Time Frame: 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 [ Time Frame: 8 days in SAD part, 17 days for MAD part ]
  Incidence of Serious Adverse Events observed during the study
• Incidence of lab deviations [ Time Frame: 8 days in SAD part, 17 days for MAD part ]
  Incidence of clinically relevant deviations in the clinical laboratory parameters

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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 2 dose levels. Evaluation of dose levels will be conducted in a sequential fashion with lower dose levels evaluated first in the sequence.
• Study Type: Interventional
• Study Phase: Phase 1

Study Design

Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Masking Description:

Double-Blind, Placebo-Controlled

Primary Purpose: Treatment

• Condition: Healthy Volunteers Only

Intervention

• Drug: 83-0060
  Oral MPro inhibitor
• Drug: Placebo
  Placebo

Study Arms

• Experimental: Single dose level 1 or placebo
  Dose level 1. SAD study part.
  Interventions:

  • Drug: 83-0060
  • Drug: Placebo
• Experimental: Single dose level 2 or placebo
  Dose level 2. SAD study part.
  Interventions:

  • Drug: 83-0060
  • Drug: Placebo
• Experimental: Single dose level 3 or placebo
  Dose level 3. SAD study part.
  Interventions:

  • Drug: 83-0060
  • Drug: Placebo
• Experimental: Single dose level 4 or placebo
  Dose level 4. SAD study part.
  Interventions:

  • Drug: 83-0060
  • Drug: Placebo
• Experimental: Single dose level 5 or placebo
  Dose level 5. SAD study part.
  Interventions:

  • Drug: 83-0060
  • Drug: Placebo
• Experimental: Multiple dose level 1 or placebo
  Dose level 1. MAD study part.
  Interventions:

  • Drug: 83-0060
  • Drug: Placebo
• Experimental: Multiple dose level 2 or placebo
  Dose level 2. MAD study part.
  Interventions:

  • Drug: 83-0060
  • Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 2, 2024): 64
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2024
• Estimated Primary Completion Date: July 2024 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Ekaterina Dokukina, MD, MPHIL; +382069728309; kdokukina@chemdiv.com

• Listed Location Countries: Australia

Administrative Information

• NCT Number: NCT06402136
• Other Study ID Numbers: 83-0060-0001; CT-2024-CTN-00084-1 ( Other Identifier: therapeutic goods administration )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Traws Pharma, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Traws Pharma, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Traws Pharma, Inc.
• Verification Date: April 2024