First in Human of Single and Multiple Doses of MOR106

Healthy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02739009
• Other study ID #: MOR106-CL-101
• Status: Completed
• Phase: Phase 1
• First received: April 1, 2016
• Last updated: October 4, 2017
• Start date: April 2016
• Est. completion date: August 1, 2017

Study information

• Verified date: October 2017
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled, dose-escalation, phase I study for the assessment of safety, tolerability and pharmacokinetics of single ascending doses of MOR106 in healthy male subjects and multiple ascending doses in subjects with moderate to severe atopic dermatitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: August 1, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Able and willing to give voluntary written informed consent

Single ascending dose (SAD)

• Negative urine drug screen

• Male between 18-50 years of age

• A body mass index (BMI) between 18-30 kg/m², inclusive.

• Judged to be in good health

Multiple ascending dose (MAD)

• Male or female between 18-65 years of age

• A BMI between 18-30 kg/m²

• Diagnosis of Atopic Dermatitis (AD) for at least 6 months as per the Hanifin and Rajka Criteria

• EASI = 16 at the screening and baseline visits

• IGA score =3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe) at the screening and baseline visits

• Greater than or equal to 10% body surface area (BSA) of AD involvement at screening

• Willingness to continue stable use of an additive free, basic, bland emollient twice daily for at least 7 days before the baseline visit

• Subject is a candidate for systemic therapy and is not responding adequately or has a contraindication to topical corticosteroids and/or topical calcineurin inhibitors (per Investigator's judgement)

• Absence of current active, latent or history of tuberculosis (TB) infection based on medical history and as determined by a negative QuantiFERON TB Gold test at screening

• Female subjects must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline

• Female subjects of childbearing potential must use a highly effective method contraception from 28 days prior to the first dose of study drug, during the study and for at least 24 weeks after the last dose

Exclusion Criteria:

• Known hypersensitivity to study drug ingredients.

• History of or a current immunosuppressive condition

• Symptoms of clinically significant illness in the 3 months before the initial study drug administration.

• Any concurrent illness, condition, disability, or clinically significant abnormality

• Treatment with any drug known to have a well-defined potential for toxicity to a major organ in the last 3 months preceding the initial study drug administration.

• A history of significant psychological, neurologic, hepatic, renal, endocrine, cardiovascular, gastrointestinal (GI), pulmonary, or metabolic disease.

MAD only

• Active (skin) infection requiring systemic antibiotics

• immunosuppressive/immunomodulating drugs or phototherapy 4 weeks prior to baseline

• Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 2 weeks before the baseline

• Treatment with biologics within 5 half-lives (if known) or 12 weeks prior to baseline visit

• history of immunosuppression

• Regular use (more than 2 visits per week) of a tanning booth/ parlor within 4 weeks of the screening visit

• Regular daily use of oral nonsteroidal anti-inflammatory drugs (NSAIDs), except low-dose aspirin (=200 mg/day) for cardioprotection, within 7 days prior to screening

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Healthy

Intervention

Drug:
• MOR106 single ascending doses, intravenous

• Placebo single ascending doses, intravenous

• MOR106 multiple ascending doses, intravenous

• Placebo multiple intravenous administrations

Locations

Country	Name	City	State
Belgium	SGS LSS Clinical Pharmacology Unit	Antwerp
Hungary	St Johns Hospital	Budapest
Moldova, Republic of	• Arensia Phase I unit	Chisinau
Romania	Arensia Phase I unit	Bucharest

Sponsors (2)

Lead Sponsor	Collaborator
Galapagos NV	MorphoSys AG

Countries where clinical trial is conducted

Belgium,  Hungary,  Moldova, Republic of,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference as compared to placebo in the number of subjects with treatment-emergent adverse events	To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo	Up to 99 days after dosing
Primary	Difference as compared to placebo in the number of subjects with deviating physical examination results	To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo	Up to 99 days after dosing
Primary	Difference as compared to placebo in the number of subjects with abnormal vital signs	To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo	Up to 99 days after dosing
Primary	Difference as compared to placebo in the number of subjects with abnormal 12-lead ECG results	To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo	Up to 99 days after dosing
Primary	Difference as compared to placebo in the number of subjects with abnormal laboratory findings	To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo	Up to 99 days after dosing
Primary	Difference as compared to placebo in the occurrence of infusion related reactions	To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo	Up to 99 days after dosing
Secondary	Serum concentration (Cinf) of MOR106	To characterize the PK of MOR106 after single intravenous administration in healthy male volunteers and after multiple ascending dose intravenous administration in subjects with severe atopic dermatitis	up to 99 days after dosing
Secondary	Area under the curve (AUC) of MOR106	To characterize the PK of MOR106 after single intravenous administration in healthy male volunteers and after multiple ascending dose intravenous administration in subjects with severe atopic dermatitis	up to 99 days after dosing
Secondary	terminal elimination half-life (t1/2) of MOR106	To characterize the PK of MOR106 after single intravenous administration in healthy male volunteers and after multiple ascending dose intravenous administration in subjects with severe atopic dermatitis	up to 99 days after dosing
Secondary	total serum clearance (CL) of MOR106	To characterize the PK of MOR106 after single intravenous administration in healthy male volunteers and after multiple ascending dose intravenous administration in subjects with severe atopic dermatitis	up to 99 days after dosing
Secondary	volume of distribution at steady state (Vss) of MOR106	To characterize the PK of MOR106 after single intravenous administration in healthy male volunteers and after multiple ascending dose intravenous administration in subjects with severe atopic dermatitis	up to 99 days after dosing
Secondary	The presence of anti-drug antibodies in serum over time after single intravenous dose	To assess the presence of anti-drug antibodies as a measure of immunogenicity after single administration of MOR106 and after multiple ascending dose intravenous administration in subjects with severe atopic dermatitis	up to 9 days after dosing