A Phase 1, Single Dose-Escalation and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous PTX-35 Adminsitration in Healthy Volunteers

Heat Biologics0 sitesNovember 24, 2021

ConditionsHealthy Volunteer

InterventionsPTX-35

DrugsPTX-35

Overview

Phase: Phase 1
Intervention: PTX-35
Conditions: Healthy Volunteer
Sponsor: Heat Biologics
Primary Endpoint: Primary
Status: Withdrawn
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

A Phase 1, Single Dose-Escalation and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous PTX-35 Adminsitration in Healthy Volunteers

Detailed Description

This is a double blind, placebo controlled, Phase 1 study of PTX-35 administered via IV infusion to healthy male and female participants. This study will be conducted in 2 stages: * Stage 1 is a single ascending dose (SAD) escalation period in which 5 dose levels of PTX-35 will be evaluated. * Stage 2 is a multiple dose period in which the highest tolerated dose determined from Stage 1 will be tested in 2 different treatment regimens in 2 cohorts (i.e., 7- and 14- days dosing regimen).

Registry

clinicaltrials.gov

Start Date

November 24, 2021

End Date

November 29, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Heat Biologics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participants must be willing and able to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.
•Healthy, male or female volunteers aged 18 to 65 years (inclusive at the time of informed consent).
•Participants must be in good general health, with no significant medical history, have no clinically significant (CS) abnormalities on physical examination, vital signs, and 12-lead ECG at Screening and/or before administration of the initial dose of study drug.
•Participants must have a body mass index (BMI) between ≥ 18.00 and ≤ 32.00 kg/m2 at Screening and a total body weight of \> 50 kg.
•Have negative tests for SARS-CoV-2, Hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV) and human immunodeficiency virus (HIV)-1 and HIV-2 antibody at Screening.
•Participants must have clinical laboratory values within normal range or abnormal and NCS as specified by the testing laboratory at Screening and admission.
•Participants must be non-smokers or social smokers who only used nicotine on 5 occasions within 90 days prior to Screening, a negative cotinine test at Screening and Day -1, and ability and willingness to refrain from tobacco products for the duration of the study (from Screening to Follow-up Visit).
•Participants must have a negative screen for alcohol and DEA Schedule II drugs at Screening and admission.
•Participants must have no relevant dietary restrictions and be willing to consume standard meals provided.
•Participants must have good venous access.

Exclusion Criteria

•Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the Follow-up period.
•Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator's (or delegate's) opinion, could adversely affect the safety of the participant, or presence of respiratory, gastrointestinal, renal, hepatic, hematologic, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.
•Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the protocol or complete the study per protocol.
•Have a Fridericia's correction factor for QT (QTcF) \> 450 ms for male participants and \> 470 ms for female participants or history of QT interval prolongation.
•Have a history of autoimmune disease, hypersensitivity, or cytokine release syndrome (CRS).
•Have a history of alcoholism or regular alcohol consumption (by self-declaration) at levels which may increase risk of harm from alcohol-related disease or injury; defined as \> 10 standard drinks per week (where 1 standard drink = 284 mL of full-strength beer, 30 mL of 40% (alc/vol) spirit, or a 100 mL glass of wine). Participant is unwilling to abstain from alcohol beginning 48 hours prior to admission to the CRU and for the duration of the study.
•A history of substance abuse or dependency in the last 12 months, or a history of recreational intravenous drug use over the last 5 years (by self-declaration), or a positive toxicology screening panel (urine test including qualitative identification of barbiturates, tetrahydrocannabinol \[THC\], amphetamines, methamphetamines, MDMA, phencyclidine, benzodiazepines, opiates, and cocaine), or alcohol breath test.
•Have a significant infection or known inflammatory process on Screening or admission.
•Fever (body temperature \> 38°C) or symptomatic viral or bacterial infection within 2 weeks prior to Screening.
•Have acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea, heartburn) at the time of Screening or admission.