A Phase I Study to Assess Cardiac and General Safety and Pharmacokinetics of 60 mg MGN1703

NCT01982747 | Completed Phase 1

• 1 other identifier: MGN1703-C04
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

MGN1703 is being developed for use in treating cancerous tumors effecting the colon, skin, kidneys and lungs. The dosage form of MGN1703 under investigation is an injection. The goal of this study is to evaluate the effects of MGN1703 on the electrical activity of the heart in healthy subjects and to look at general safety.

Conditions

Healthy

Keywords

Cardiac Safety; General Safety; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• cardiac safety of MGN1703 as compared to placebo

  assessed by 12 lead ECG

  within the first 5 days after dosing

Secondary Outcomes (1)

• general safety of MGN1703 as compared to placebo

  within 5 days after dosing

Other Outcomes (1)

• PK parameters of MGN1703

  within 5 days after dosing

Study Arms (2)

MGN - Placebo

OTHER

Subjects of the MGN-Placebo arm will receive 60mg MGN1703 as 2 s.c. injections of 2 ml each during period 1 and physiological saline solution as Placebo as 2 s.c. injections of 2 ml each during period 2

Drug: MGN-Placebo

Placebo-MGN

OTHER

Subjects of the Placebo-MGN arm will receive physiological saline solution as Placebo as 2 s.c. injections of 2 ml each during period 1 and 60mg MGN1703 as 2 s.c. injections of 2 ml each during period 2

Drug: Placebo-MGN

Interventions

MGN-Placebo DRUG

MGN - Placebo

Placebo-MGN DRUG

Placebo-MGN

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject signs an IRB/IEC-approved informed consent prior to any study-related procedures.
• Subject is male or female with no less than 6 subjects per sex in the study.
• Subject is 18 to 65 years of age.
• Subject's BMI is ≤32 kg/m2.
• Female subjects of childbearing potential must not be pregnant or lactating with a negative serum HCG pregnancy test result at Screening and a negative urine HCG pregnancy test result on Days -1 and 14 prior to receiving study medication.
• Female subjects of childbearing potential and male subjects must use an adequate method of contraception from Screening until completion of the study. Acceptable methods of contraception are barrier methods (male condom, female condom, diaphragm, cervical cap, spermicide or IUD), surgical sterility (documented doctor's report of vasectomy, hysterectomy and/or bilateral oophorectomy) and/or postmenopausal status (defined as at least 1 year without menses as demonstrated by medical history or subject report).
• Subject is in good health as determined by vital signs, medical history, physical exam, and safety laboratory analyses at Screening and during the study.

You may not qualify if:

• Subject has used an investigational product within 30 days prior to screening or during the study.
• Subject has used prescription or non-prescription drugs (including vitamins, minerals, and herbal/plant-derived preparations) within 2 weeks of Screening (excluding oral contraceptives, hormonal IUD, hormone replacement therapy and acetaminophen) unless deemed acceptable by the Investigator in consultation with the Sponsor.
• Subject has a positive drug and/or alcohol test at Screening, Day -1 or Day 14.
• The subject has a history of drug or alcohol abuse within 2 years before Screening.
• The subject is unable to abstain from ingesting alcohol, caffeine, grapefruit or Grapefruit juice for 72 hour prior to dosing.
• The subject has a clinically significant history of cardiovascular, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major diseases or malignancy.
• Subject has a history of cardiac disease or any risk factors for TdP including (but not limited to) unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia, structural heart disease and family history of Long QT syndrome.
• Subject has evidence of any of the following cardiac conduction abnormalities at Screening, Day -1 or Day 1 prior to receiving any study medication:
• QTcF interval \>430 msec for males and \>450 msec for females
• PR interval \>240 msec or \<110 msec
• Evidence of second- or third-degree AVB
• Electrocardiographic evidence of complete LBBB, complete RBBB or incomplete LBBB
• Intraventricular conduction delay with QRS duration \>120 msec
• Heart rate \<40 bpm or \>90 bpm
• Pathological Q waves (defined as \>40 msec or depth \>0.4-0.5 mV)

Sponsors & Collaborators

• Mologen AG: lead

Study Sites (1)

Spaulding Clinical

West Bend, Wisconsin, 53095, United States

Location

Study Officials

• Carlos R Sanabria, MD

  Spaulding Clinical

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 6, 2013
• First Posted: November 13, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 19, 2014

Record last verified: 2014-05

Locations

US (1)