Safety, Tolerability and Pharmacokinetic Profiles of MOTREM (LR12) in Healthy Male Subjects

Inotrem

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Placebo; Drug: nangibotide

Study type: Interventional

Funder types: Industry

Identifiers

NCT03463044

MOT-C-104

Details and patient eligibility

About

This was a single center, randomized, placebo-controlled study with a sequential i.v. dose escalation cohorts design, to assess safety, tolerability and pharmacokinetics of MOTREM (nangibotide) in healthy volunteers

Full description

This was a dose escalation study in healthy volunteers to evaluate the safety and pharmacokinetics of nangibotide in humans

Enrollment: 27 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• healthy male
• ≥18 to ≤45 years old
• Body mass index (BMI) between 18-30 kg/m² inclusive
• Written informed consent to participate.

Main Exclusion Criteria:

• Any clinically relevant acute or chronic diseases
• Any history of drug or alcohol abuse
• Any History of clinical significant disease as determined by medical history, physical examination or other evaluations.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

27 participants in 9 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Matched placebo

Treatment:

Drug: Placebo

MOTREM 1

Experimental group

Description:

nangibotide dose 1

Treatment:

Drug: nangibotide

MOTREM 2

Experimental group

Description:

Nangibotide dose 2

Treatment:

Drug: nangibotide

MOTREM 3

Experimental group

Description:

Nangibotide dose 3

Treatment:

Drug: nangibotide

MOTREM 4

Experimental group

Description:

Nangibotide dose 4

Treatment:

Drug: nangibotide

MOTREM 5

Experimental group

Description:

Nangibotide dose 5

Treatment:

Drug: nangibotide

MOTREM 6

Experimental group

Description:

Nangibotide dose 6

Treatment:

Drug: nangibotide

MOTREM 7

Experimental group

Description:

Nangibotide dose 7

Treatment:

Drug: nangibotide

MOTREM 8

Experimental group

Description:

Nangibotide dose 8

Treatment:

Drug: nangibotide