A Single Increasing Dose Study to Assess Safety and Tolerability of DX-2930 in Healthy Subjects

NCT01923207 | Completed Phase 1

• 1 other identifier: DX-2930-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety and tolerability of the study drug (DX-2930) administered subcutaneously in healthy subjects. Subjects will be randomized to receive DX-2930 or placebo.

Conditions

Hereditary Angioedema (HAE)

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with adverse events

  112 days

Secondary Outcomes (1)

• DX-2930 plasma level

  112 days

Study Arms (2)

DX-2930

EXPERIMENTAL

DX-2930 administered by subcutaneous route

Drug: DX-2930

placebo

PLACEBO COMPARATOR

inactive formulation of DX-2930

Drug: Placebo

Interventions

DX-2930 DRUG

DX-2930

Placebo DRUG

placebo, subcutaneous administration

placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female subjects who are 18 to 55 years of age, inclusive.
• Willing and able to read, understand, and sign an informed consent form.
• Willing and able to receive subcutaneous injections.
• Body mass index (BMI) of 18 to 33 kg/m2 with a weight of at least 60 kg for males and at least 50 kg for females, with a maximum weight of 130 kg for any subject.
• Medically healthy as determined by the investigator via assessment of physical examination, medical history, clinical laboratory tests, vital signs, and electrocardiogram (ECG).
• Females of childbearing potential must agree to be abstinent or else use any two of the following medically acceptable forms of contraception from the Screening Period through 30 days after the final study visit: condom with spermicidal jelly, diaphragm or cervical cap with spermicidal jelly, or intra-uterine device (IUD). A female whose male partner has had a vasectomy must agree to use one additional form of medically acceptable contraception. Female subjects must agree to practice the above birth control methods for 30 days after the final study visit as a safety precaution.
• Females of non-childbearing potential, defined as surgically sterile (status post hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or post-menopausal for at least 12 months (and confirmed with a screening follicle-stimulating hormone (FSH) level in the post-menopausal range), do not require contraception during the study.
• Males with female partners of childbearing potential must agree to use a highly effective, medically acceptable form of contraception from the screening period through 60 days after the final study visit. All male subjects, including males who are surgically sterile (post vasectomy), must agree to practice the above birth control methods for 60 days from the final study visit as a safety precaution.

You may not qualify if:

• Any active acute or chronic illness at screening.
• Any history of exposure to a biologic within 90 days prior to dosing.
• Receipt of any investigational (a non-licensed, non-approved) drug or device within 60 days prior to dosing.
• Any prior history of exposure to a monoclonal antibody.
• Pregnant or actively breastfeeding.
• Any history of substance abuse or dependence.
• Positive urine drug or alcohol test at screening or Day -1 for amphetamines, benzodiazepines, barbiturates, cocaine, cotinine (detection mechanism for nicotine), marijuana, opiates, phencyclidine or ethanol.
• Regular use of alcohol within six months prior to the screening visit \[more than fourteen units of alcohol per week (1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol)\].
• Use of prescription or over-the-counter medication within 14 days prior to administration of study medication, or use of over-the-counter products (dietary or herbal supplements and vitamins) within 14 days prior to administration of study medication.
• Use of nicotine or nicotine-containing products within the previous three months prior to screening.
• Subject has any other condition, which in the opinion of the investigator may compromise the safety or compliance or would preclude the subject from successful completion of the study or interfere with the interpretation of the results.
• Abnormal clinical laboratory values and/or other study assessments such as ECG results deemed to be clinically significant by the investigator.
• Donation of blood within 60 days preceding Study Day -1.
• Serology testing positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).

Sponsors & Collaborators

• Shire: lead
• Dyax Corp.: collaborator

Study Sites (1)

Vince and Associates Clinical Research

Overland Park, Kansas, 66212, United States

Location

Related Publications (1)

• Chyung Y, Vince B, Iarrobino R, Sexton D, Kenniston J, Faucette R, TenHoor C, Stolz LE, Stevens C, Biedenkapp J, Adelman B. A phase 1 study investigating DX-2930 in healthy subjects. Ann Allergy Asthma Immunol. 2014 Oct;113(4):460-6.e2. doi: 10.1016/j.anai.2014.05.028. Epub 2014 Jun 26.

  PMID: 24980392 RESULT

MeSH Terms

Conditions

Angioedemas, Hereditary

Interventions

lanadelumab

Condition Hierarchy (Ancestors)

Angioedema; Vascular Diseases; Cardiovascular Diseases; Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Immunologic Deficiency Syndromes

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2013
• First Posted: August 15, 2013
• Study Start: August 12, 2013
• Primary Completion: January 7, 2014
• Study Completion: January 7, 2014
• Last Updated: May 17, 2021

Record last verified: 2021-05

Locations

US (1)