Phase 1
Completed N=27
Safety, Tolerability and Pharmacokinetic Profiles of MOTREM (LR12) in Healthy Male Subjects
Healthy Subjects
Source: ClinicalTrials.gov NCT03463044 ↗
Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcomePrimary: Safety and Tolerability: the Number of Subjects Experiencing Treatment Emergent Adverse Events — 1; 0; 1; 1 Participants
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability: the Number of Subjects Experiencing Treatment Emergent Adverse Events |
1; 0; 1; 1; 1; 0 | — |
| SECONDARY Pharmacokinetics (Maximum Plasma Concentration) |
256.20; 638.04; 1643.25; 3818.94; 4185.47; 4200.05 | — |
| SECONDARY Statistical Analysis of LR12 PK Parameters: Steady State Concentration During the Maintenance Infusion (Cavg30-465) |
NA; 13.46; 36.61; 152.41; 418.05; 983.19 | — |
| SECONDARY Statistical Analysis of LR12 PK Parameters: t1/2 |
NA; NA; NA; 1.63; 17.87; 40.70 | — |
| SECONDARY Statistical Analysis of LR12 PK Parameters: AUC0-t |
101.98; 244.38; 661.60; 2153.14; 4208.65; 8556.69 | — |
| SECONDARY Statistical Analysis of LR12 PK Parameters: AUC0-∞ |
NA; NA; NA; 2153.38; 4211.90; 8565.30 | — |
| SECONDARY Statistical Analysis of LR12 PK Parameters: CL |
NA; 9.47; 6.79; 6.73; 5.66; 7.50 | — |
| SECONDARY Statistical Analysis of LR12 PK Parameters: Volume of Distribution (V) |
NA; NA; NA; 0.26; 2.43; 7.34 | — |
| SECONDARY Statistical Analysis of LR12 PK Parameters: Tmax |
15; 15; 15; 15; 5; 5 | — |
| SECONDARY Statistical Analysis of LR12 PK Parameters: t Last |
465; 484; 484; 487; 510; 600 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03463044). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.