A Phase 1 Study of PTX-35 in Healthy Volunteers

NCT05116969 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: PTX35-101
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Primary

  To establish the safety number and severity of adverse events of PTX-35 in healthy male and female volunteers

  Up to 60 days

Study Arms (7)

Stage 1: PTX-35 Dose Level 1

EXPERIMENTAL

Dose Level 1: PTX-35 0.1 mg/kg

Drug: PTX-35

Stage 1: PTX-35 Dose Level 2

EXPERIMENTAL

Dose Level 2: PTX-35 0.3 mg/kg

Drug: PTX-35

Stage 1: PTX-35 Dose Level 3

EXPERIMENTAL

Dose Level 3: PTX-35 1.0 mg/kg

Drug: PTX-35

Stage 1: PTX-35 Dose Level 4

EXPERIMENTAL

Dose Level 4: PTX-35 3.0 mg/kg

Drug: PTX-35

Stage 1: PTX-35 Dose Level 5

EXPERIMENTAL

Dose Level 5: PTX-35 10.0 mg/kg

Drug: PTX-35

Stage 2 Multiple Ascending Dose Regimen 6

EXPERIMENTAL

4 doses of PTX-35 with each dose separated by 7 days

Drug: PTX-35

Stage 2 Multiple Ascending Dose Regimen 7

EXPERIMENTAL

3 doses of PTX-35 with each dose separated by 14 days

Drug: PTX-35

Interventions

PTX-35 DRUG

PTX-35 is a humanized, affinity matured, IgG2 monoclonal antibody

Stage 1: PTX-35 Dose Level 1; Stage 1: PTX-35 Dose Level 2; Stage 1: PTX-35 Dose Level 3; Stage 1: PTX-35 Dose Level 4; Stage 1: PTX-35 Dose Level 5; Stage 2 Multiple Ascending Dose Regimen 6; Stage 2 Multiple Ascending Dose Regimen 7

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Females must be not be pregnant and lactating, and must use an acceptable, highly effective double contraception from Screening until study completion, including the Follow-up period unless surgically sterile. Double contraception is defined as a condom AND one other form of the following:
• Established hormonal contraception (with approved oral contraceptive pills \[OCPs\], long-acting implantable hormones, injectable hormones);
• A vaginal ring or an intrauterine device (IUD);
• Participants that are surgically sterile must have documented evidence of surgical sterilization at least 6 months prior to Screening (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy for women or vasectomy for men \[with appropriate post-vasectomy documentation of the absence of sperm in semen\] provided the male partner is a sole partner).
• Women not of childbearing potential must be post menopausal for ≥ 12 months. Post menopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels ≥ 40 IU/L at Screening for amenorrhoeic female participants. Females who are abstinent from heterosexual intercourse will also be eligible.

You may not qualify if:

• 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.
• Blood donation or significant blood loss within 60 days prior to the first study drug administration.
• Plasma donation within 7 days prior to the first study drug administration.
• History of severe allergic or anaphylactic reactions.
• History of malignancy, except for non-melanoma skin cancer, excised more than 2 years ago and cervical intraepithelial neoplasia that has been successfully cured more than 5 years prior to Screening.
• Abnormal ECG findings at Screening that are considered by the Investigator to be CS.

Sponsors & Collaborators

• Heat Biologics: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 11, 2021
• Study Start: November 24, 2021
• Primary Completion: November 29, 2022
• Study Completion: November 29, 2022
• Last Updated: February 17, 2022

Record last verified: 2022-02