Phase 1 N=12 Randomized Double-blind Treatment

A Study to Determine the Safety, Tolerability, and Pharmacokinetics of Lanadelumab Administered Intravenously in Healthy Adult Volunteer Participants

Healthy Volunteers

Bottom Line

View on ClinicalTrials.gov: NCT04503603 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2022

Primary outcome: Primary: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) — 7; 2 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Lanadelumab (Drug); Placebo (Other)
Age: Adult · 19+ yrs
Sex: All
Sponsor: Takeda
Primary completion: Dec 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)	7; 2	—
PRIMARY Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters	0; 0	—
PRIMARY Number of Participants With Clinically Significant Change From Baseline in Vital Signs	0; 0	—
PRIMARY Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings	0; 0	—
PRIMARY AUC0-last: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration for Lanadelumab	32955	—
PRIMARY AUC0-inf: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity for Lanadelumab	33305	—
PRIMARY Cmax1: Maximum Observed Plasma Concentration Following the First IV Dose for Lanadelumab	75.6	—
PRIMARY Cmax2: Maximum Observed Plasma Concentration Following the Second IV Dose for Lanadelumab	120	—
PRIMARY Tmax1: Minimum Observed Time to Reach the First Cmax1 for Lanadelumab	2.01	—
PRIMARY Tmax2: Minimum Observed Time to Reach the Second Cmax2 for Lanadelumab	74.03	—
PRIMARY Terminal Half-Life (T1/2) of Lanadelumab in Plasma	19.3	—
PRIMARY Clearance (CL) of Lanadelumab in Plasma	18.1	—
PRIMARY Vss: Volume of Distribution at Steady State in Plasma for Lanadelumab	8070	—
PRIMARY First Order Elimination Rate Constant Associated With the Terminal (Log-linear) Portion of the Curve (Lambda z) of Lanadelumab	9.90	—

Summary

The purpose of this study to evaluate the safety, tolerability and pharmacokinetics (PK) of lanadelumab administered by Intravenous (IV) infusion in healthy adult volunteers.

Eligibility Criteria

Inclusion Criteria

Healthy, adult, male or female, 19-55 years of age, inclusive, at screening.
Continuous non-smoker who has not used nicotine-containing products for at least 30 days prior to the first dosing and throughout the study, based on participant self-reporting.
Body mass index (BMI) greater than or equal to (>=) 18.0 and less than or equal to ( ) 20 mmHg or decrease in diastolic > 10 mmHg and increase in pulse of > 20 beats per minute.
QTcF interval is > 450 milliseconds (msec) (males) or > 470 msec (females) or ECG findings are deemed abnormal with clinical significance at screening per the investigator.
Estimated creatinine clearance less than (<) 80 milliliters per minute (mL/min) at screening.
Unable to refrain from or anticipates the use of any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements within 14 days prior to the first dosing and throughout the study. Medication listed as part of acceptable birth control methods will be allowed. Thyroid hormone replacement medication may be permitted if the participant has been on the same stable dose for the immediate 3 months prior to first study drug administration. After randomization/dosing, a nonsteroidal anti-inflammatory drug may be administered at the discretion of the investigator. Hormone replacement therapy will also be allowed if the participant has been on the same stable dose for the immediate 3 months prior to first study drug administration.
Has been on a diet incompatible with the on-study diet, per the investigator, within the 30 days prior to the first dosing and throughout the study.
Donation of blood or significant blood loss within 56 days prior to the first dosing.
Plasma donation within 7 days prior to the first dosing.
Participation in another clinical study within 30 days or 5 half-lives prior to the first dosing. The 30-day window or 5 half-lives will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of the current study

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Data sourced from ClinicalTrials.gov (NCT04503603). 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.