Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of Intravenous (IV) Infusion of MTP-131 (Bendavia™) in Healthy Adults

Stealth BioTherapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: MTP-131 (Bendavia™)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01115920

SPIRI-101

Details and patient eligibility

About

This is the first study of MTP-131 (Bendavia™) in humans. The objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single intravenous infusion doses of MTP-131.

Full description

The primary objective of the study is to evaluate the safety and tolerability of MTP-131 in healthy volunteers following a single intravenous infusion. The secondary objective is to evaluate the pharmacokinetics of MTP-131. This is a double-blind, placebo-controlled, randomized trial. A total of 40 eligible subjects will be enrolled and randomized in a 3:1 active to placebo ratio for a total of 5 treatment groups of 8 volunteers. As far as is logistically possible, each treatment group will have similar numbers of male and female volunteers. After the last subject for each cohort has completed the day 3 clinical assessment and no stopping rules have been met according to Safety Review Board decision, the next cohort will commence.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adult males or females age ≥18 years of age with signed informed consent.
• Women who are not post-menopausal or surgically sterile must have a negative serum pregnancy test at screening and within 24 hours of treatment and who agree to use effective contraception for 30 days following the study.

Exclusion criteria

• Clinically significant laboratory abnormalities,

• Clinically significant abnormalities on physical examination,

• BMI of less than 18 kg/m2 or greater than 32 kg/m2,

• Any disease or condition that might compromise the cardiovascular, hematological, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) systems,

• History of seizures or epilepsy,

• History of serious mental illness,

• Participant in unrelated research involving investigational product within 30 days before planned date of drug administration,

• Positive serology for HIV 1, HIV 2, HBsAg, or HCV,

• Fever greater than 37.5°C at the time of planned dosing,

• Suspicion of or recent history of alcohol or substance abuse,

• Donated blood or blood products within the past 30 days,

• Women who are pregnant or breastfeeding,

• Employee or family member of the investigational site, and

• Subjects who currently smoke cigarettes, cigars, pipes or chew tobacco products,

• Subjects who are either unwilling to agree to refrain from use or found to be using:

  1. Alcohol, caffeine, xanthine-containing food or beverages, nicotine products and over-the-counter medications with the exception of Tylenol from 24 hours prior to dosing and throughout the confinement period
  2. Prescription medications from 14 days prior to and 7 days post treatment
  3. Oral contraceptives without concomitant use of double-barrier contraceptives (condom, diaphragm with spermicide) for a period of 7 days prior to and 30 days post treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 5 patient groups

Arm 1

Experimental group

Description:

Cohort 1, Dose 0.010 mg/kg/hr Active (6), Placebo (2), Total Subjects (8)

Treatment:

Drug: MTP-131 (Bendavia™)

Arm 2

Experimental group

Description:

Cohort 2, Dose 0.025 mg/kg/hr Active (6), Placebo (2), Total Subjects (8)

Treatment:

Drug: MTP-131 (Bendavia™)

Arm 3

Experimental group

Description:

Cohort 3, Dose 0.050 mg/kg/hr Active (6), Placebo (2), Total Subjects (8)

Treatment:

Drug: MTP-131 (Bendavia™)

Arm 4

Experimental group

Description:

Cohort 4, Dose 0.100 mg/kg/hr Active (6), Placebo (2), Total Subjects (8)

Treatment:

Drug: MTP-131 (Bendavia™)

Arm 5

Experimental group

Description:

Cohort 5, Dose 0.250 mg/kg/hr Active (6), Placebo (2), Total Subjects (8)

Treatment:

Drug: MTP-131 (Bendavia™)