Anti-Shiga Toxin Hyperimmune Equine Immunoglobulin F(ab')2 Fragment (INM004) in Healthy Volunteers

NCT03388216 | Completed Phase 1 DMC

• 1 other identifier: CT-INM004-01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This is Prospective Randomized Placebo controlled Single Blind Phase I study to evaluate the safety, tolerance and pharmacokinetics of the anti-Shiga toxin hyperimmune equine immunoglobulin F(ab')2 fragment (INM004) in healthy volunteers.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (5)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  4 weeks

• Maximum Plasma Concentration [Cmax]

  4 weeks

• Area Under the Curve [AUC]

  4 weeks

• Elimination half-life (t½)

  4 weeks

• Time of Maximum concentration observed (Tmax)

  4 weeks

Secondary Outcomes (1)

• Number of participants with treatment-related hypersensitivity events as assessed by CTCAE v4.0

  4 weeks

Study Arms (6)

Stage I - Drug: INM004 Dose 1

EXPERIMENTAL

Biological: Drug: INM004 Dose 1

Stage I - Placebo Dose 1

PLACEBO COMPARATOR

Other: Placebo

Stage I- Drug: INM004 Dose 2

EXPERIMENTAL

Biological: Drug: INM004 Dose 2

Stage I- Placebo Dose 2

PLACEBO COMPARATOR

Other: Placebo

Stage II- Drug: INM004 Repeated Dose

EXPERIMENTAL

Biological: Drug: INM004- Repeated dose

Stage II- Placebo Repeated Dose

PLACEBO COMPARATOR

Other: Placebo

Interventions

Drug: INM004 Dose 1 BIOLOGICAL

Stage I- Cohort I: (2mg/kg) administered at a single dose. The ratio is 3:1 (investigational product:placebo) -

Stage I - Drug: INM004 Dose 1

Drug: INM004 Dose 2 BIOLOGICAL

Stage I- Cohort II: Dose 2 (4mg/kg) administered at a single dose. The ratio is 3:1 (investigational product:placebo)

Stage I- Drug: INM004 Dose 2

Drug: INM004- Repeated dose BIOLOGICAL

Stage II: Either 3 doses of 2 mg/kg or 4 mg/kg will be administered every 24 hs. The ratio is 5:1 (investigational product : placebo).

Stage II- Drug: INM004 Repeated Dose

Placebo OTHER

A placebo infusion will be administered at the same infusion rate as the Drug arm

Stage I - Placebo Dose 1; Stage I- Placebo Dose 2; Stage II- Placebo Repeated Dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index: between 19 and 27.
• Healthy subject, as determined by clinical exam, medical history and laboratory tests (chemistry, hematology and urine, pregnancy test if applicable) performed during the screening visit.
• Chest x-ray and electrocardiogram within normal ranges.
• Willing to participate and sign the informed consent.
• Women of child-bearing potential using at least two barrier birth control methods.
• Sexually active men using medically accepted birth control methods, such as condom with spermicide.

You may not qualify if:

• Known hypersensitivity to equine serum.
• Hypersensitivity to any of the components of the pharmaceutical preparation.
• History of severe allergic reactions to any type of antigen.
• History of mental illness.
• Participation in another clinical research study within 90 days6 months prior to the start of this study
• History of alcohol or drug abuse.
• History or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, hematological, neurological disease.
• Having received contrast substances for radiological studies of any kind in the two weeks prior to the start of the study.
• Receiving or having received any prescription drug within the two weeks prior to the start of the study, including oral contraceptives in women of child-bearing potential.
• Having received more than three doses of any over-the-counter medication during the week prior to the start of the study or any medication within two days prior to the hospitalization
• Having given blood within a period of under 2 months prior to the start of the study
• Documented infection with HIV, hepatitis B and/or hepatitis C.
• Pregnancy
• History of asthma, allergy, prior administration of equine serum (por example, anti-tetanus serum or anti-ophidic serum or anti-arachnid toxin serum) or allergic reaction due to contact or exposure to horses.
• History of vaccination within the month prior to the start of the study.

Sponsors & Collaborators

• Inmunova S.A.: lead
• Hospital Italiano de Buenos Aires: collaborator

Study Sites (1)

Hospital Italiano de Buenos Aires

Ciudad Autónoma de Buenos Aire, Argentina

Location

Study Officials

• Santiago Sanguineti, Ph.D

  Inmunova S.A.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: January 2, 2018
• Study Start: December 16, 2017
• Primary Completion: September 27, 2018
• Study Completion: September 28, 2018
• Last Updated: February 27, 2019

Record last verified: 2019-02

Locations

AR (1)